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Clinical efficacy and safety of Paxlovid in the treatment of severe adult patients with SARS-Cov-2 infection: a multicenter, randomized, controlled study

Clinical efficacy and safety of Paxlovid in the treatment of severe adult patients with SARS-Cov-2 infection: a multicenter, randomized, controlled study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058477
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-11
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corona Virus Disease 2019, COVID-19

Interventions

Group 1 :Standard COVID-19 Treatment Protocol
Group 2:Combined with Paxlovid

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age above 18 years and below 90 years; 2. Hospitalized patients with mild or common type of SARS-CoV-2 confirmed by PCR, whose last nucleic acid sampling time was within 48 hours before inclusion; 3. Within 48 hours after admission; 4. PCRCt value of viral nucleic acid in nasal/pharyngeal swabs = 2 points or charson score >= 2 points due to other non-COVID-19 causes; 6. The patient was fully informed and agreed to participate in the study and expected to complete the treatment and examination related to the study.

Exclusion criteria

Exclusion criteria: 1. A history of COVID-19 infection; 2. A known history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-PughB or C grade, or acute liver failure; 3. Receiving dialysis or known moderate to severe renal impairment (i.e., EGFR = 2.5 times the upper limit of normal; (2) Total bilirubin >= 2 times the normal high limit; (3) Absolute count of neutrophils < 1000 /mm^3; glomerular filtration rate < 45 ml/min /1.73m2 within 3 months; 10. Breastfeeding or pregnant women.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Inpatient mortality;Conversion rate of severe COVID-19 within 14 days;Acute exacerbation rate of chronic underlying diseases within 14 days;Nucleic acid negative rate within 7 days;Nucleic acid negative conversion rate within 14 days;Nucleic acid negative time;Total in-hospital days;Duration of stay in ICU;Percentage requiring organ function support within 28 days;

Countries

China

Contacts

Public ContactDechang Chen

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

chendechangsh@hotmail.com+86 18918520002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026